Randomized Controlled Trial of Human Papillomavirus Testing in Primary Cervical Cancer Screening - Tabular View

Tracking Information

First Received Date ^ICMJE

May 25, 2007

Last Updated Date

May 25, 2007

Start Date ^ICMJE

May 1997

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Incidence of CIN2/CIN3+ lesions (which includes invasive cancers and in situ adenocarcinomas) found by subsequent screening (i.e. after the enrollment screening round and its associated follow-up). [ Time Frame: On average 4 years post baseline ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Secondary outcomes were the incidence of CIN2/CIN3+ lesions at enrollment screening (including associated follow-up) and outcomes stratified by CIN2 and CIN3+ lesions as endpoints. [ Time Frame: On average 4 years post baseline ]
Re-analysis of primary and secondary outcomes also after subsequent 3-yearly screening rounds [ Time Frame: On average 7, 10, 13 (et cetera) years post base-line ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Randomized Controlled Trial of Human Papillomavirus Testing in Primary Cervical Cancer Screening

Official Title ^ICMJE

Randomized Controlled Trial of Human Papillomavirus Testing in Primary Cervical Screening

Brief Summary

Human papillomavirus (HPV)-based cervical screening is known to increase sensitivity for detection of high-grade cervical intraepithelial neoplasia (CIN). Randomized trials of longitudinal efficacy are required to assess whether these gains represent overdiagnosis or a protective effect.

Methods: A total of 12527 women, aged 32-38, attending population-based invitational screening in Sweden were randomized 1:1 to HPV test and cytology (intervention arm) or cytology only (control arm). HPV-positive women were invited for a second HPV test at least one year later and women with type-specific persistent infections were then invited to colposcopy. A similar number of random double-blinded procedures are performed in the control arm. Women are followed with comprehensive registry-based follow-up. Primary outcome is the relative rates of CIN grade 2 or worse (CIN2/CIN3+) found in subsequent screening. Secondary outcomes are the relative rates of CIN2/CIN3+ found in the aseline screening and outcomes stratified by grade of CIN (CIN 2 or CIN3+).

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Screening, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Cervical Cancer
Cervical Intraepithelial Neoplasia

Intervention ^ICMJE

Procedure: Adding Human Papillomavirus testing to organised cervical screening

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

12527

Completion Date

May 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Women aged 32-38 years old
Attending the Swedish population-based organised cervical screening program

Exclusion Criteria:

Not providing informed consent

Gender

Female

Ages

32 Years to 38 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Sweden

Administrative Information

NCT ID ^ICMJE

NCT00479375

Responsible Party

Study ID Numbers ^ICMJE

3824-B00-05XAC

Study Sponsor ^ICMJE

Malmö University Hospital

Collaborators ^ICMJE

Swedish Cancer Society
Europe Against Cancer (European Union Directorate General XII- Public Health)

Investigators ^ICMJE

Principal Investigator:

Joakim Dillner, MD

Malmo University Hospital, Lund University

Information Provided By

Malmö University Hospital

Verification Date

May 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP